MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-4254
Medical Device Problem Codes	Use of Device Problem (1670); Structural Problem (2506)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-surg acc, upn: (b)(4), model : sc-4254, serial : n/a, lot: 24397747.
Event or Problem Description
It was reported that during a deep brain stimulator implant procedure, the physician experienced difficulty using the tunneling tools when trying to implant the lead extension.The physician used two different tunneling tools which both bent and damaged the silicone on the tools.The physician then had to make an additional incision in the middle of the patients neck to pass the tunneling tool to the chest in which the lead extension was successfully implanted.The patient is doing well post-operatively.The devices will not be returned as they were disposed of by the medical facility.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11038606
• Report Number: 3006630150-2020-06272
• Device Sequence Number: 1046743
• Product Code: LGW
• UDI-Device Identifier: 08714729762751
• UDI-Public: 08714729762751
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/13/2021
• Device Model Number: SC-4254
• Device Catalogue Number: SC-4254
• Device Lot Number: 24397806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 32